Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01688102
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Vitamin D 25-OH level \< 20 ng/ml
Exclusion Criteria:
1. Serum calcium \> 10.5 mg/dl
2. Serum phosphorus \> 5.5 mg/dl
3. Serum parathyroid hormone (PTH) level \< 12 pg/ml
4. LDL cholesterol \> 190 mg/dl
5. History of recent acute infection (within 1 month)
6. Glomerular filtration rate(GFR) \< 60 mL/min
7. Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) \> 3x ULN)
8. Current use of Vitamin D \> 400 IU/day
9. Current use of any statins, fibrates, niacin, or ezetimibe
10. Current use of any medications affecting sensitivity to UV light
11. Pregnancy (self-reported)
12. Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study
13. history of malignancy not in remission (\> 6 months)
14. History of malignant melanoma
15. Participation in an investigational drug study within 30 days of the screening visit
16. Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
17. History of any non-melanoma skin cancer
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01688102
Study Brief:
Protocol Section:
NCT01688102